Device
TBS BASICS Flexi-Thin Composite Contouring Instrument, Paddle & Plugger, Titanium Coated, #9 Hollow Handle
Manufacturer
ACME ENTERPRISE.
ACME ENTERPRISE.
Model: TBSB401
Catalog: TBSB401
DI: G149TBSB4010
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
TBS BASICS Flexi-Thin Composite Contouring Instrument, Paddle & Plugger, Titanium Coated, #9 Hollow Handle
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ffd234d6-6e37-4da3-98dc-2d3e8bc75080
Distribution Status:
In Commercial Distribution
DUNS Number:
645459892
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G149TBSB4010
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 41861
Name: Dental restoration carver, resin
Definition:
A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.
FDA Product Codes
EIY
Instrument, Filling, Plastic, Dental